Plain-English translation of NCT05313308 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Epilepsy research guide →This study is tracking the safety and effectiveness of oromucosal solution, a medication designed to stop seizures quickly when they happen. The research is taking place in Japan and will follow patients for 6 months after they receive this medication during a seizure. Doctors want to understand whether the medication works well and what side effects patients may experience.
Status epilepticus is a serious, life-threatening seizure condition that requires rapid treatment. This study exists to gather real-world information about how safely and effectively this medication works when used in regular clinical practice, rather than only in controlled research settings.
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You will receive the medication as part of your regular seizure care when a seizure occurs — the dose depends on your age. After that, clinic staff will monitor you and record any side effects you experience for 6 months. The researchers will collect this information but won't change how your doctors treat you; they're simply observing and documenting what happens during routine care.
AI-generated summary from trial data · Jun 13, 2026 · Not medical advice
Japan
Enrollment target
~50 participants
Started
June 2021
Primary completion
August 2028
Last updated on clinicaltrials.gov in May 2026.
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Central contact
Clinigen Contact
Clinigen K.K.
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